On the glycosylation aspects of biosimilarity.

On the glycosylation aspects of biosimilarity.
Drug Discov Today. 2018 Jan 11;:
Authors: Hajba L, Szekrényes Á, Borza B, Guttman A
Abstract
The recent expiration of several protein therapeutics opened the door for biosimilar development. Biosimilars are biologic medical products that are similar but not identical copies of already-authorized protein therapeutics. Critical quality attributes (CQA), such as post-translational modifications of recombinant biotherapeutics, are important for the clinical efficacy and safety of both the innovative biologics and their biosimilar counterparts. Here, we summarize biosimilarity CQAs, considering the regulatory guidelines and the statistical aspects (e.g., biosimilarity index) and then discuss glycosylation as one of the important attributes of biosimilarity. Finally, we introduced the 'Glycosimilarity Index', which is based on the averaged biosimilarity criterion.
PMID: 29337201 [PubMed - as supplied by publisher]

Source: Drug Discovery Today - January 11, 2018 Category: Drugs & Pharmacology Authors: Hajba L, Szekrényes Á, Borza B, Guttman A Tags: Drug Discov Today Source Type: research